Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were randomized in a 1:1 ratio and the randomization was stratified by geographic region (Australia versus Eastern Europe versus Western Europe versus North America), Karnofsky performance status (70 to 80 versus 90 to 100), and by the presence of liver metastases (yes versus no)

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

38 participants were randomized but not treated due to the participants request to withdraw after the randomization results became known. 1 participant was randomized to Gemcitabine and was treated with Albumin-bound paclitaxel ABI-007/Gemcitabine in error and analyzed as treated and included in the intent to treat population (ITT)

Reporting Groups

Description

Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)

Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest

Gemcitabine (Gem)

Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)

Participant Flow: Overall Study

Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)

Gemcitabine (Gem)

STARTED

431
[1]

430
[1]

Treated Population

421
[2]

402
[2]

COMPLETED

26
[3]

12
[3]

NOT COMPLETED

405

418

Progressive Disease

196

245

Adverse Event

128

73

Physician Decision

25

18

Protocol Violation

10

6

Withdrawal by Subject

28

39

Unspecified

7

10

Withdrew prior to starting treatment

11

27

[1]

Started = Intent to Treat Population and includes all randomized participants

[2]

Treated population = all randomized patients who received at least one dose of study drug

[3]

Completed = participants remaining on treatment at the time of the data cut off 17 Sept 2012

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

For the KPS baseline characteristic, some of the participants did not have a baseline KPS recorded by the clinical site.

Reporting Groups

Description

Albumin-bound Paclitaxel (ABI-007)/Gemcitabine

ABI-007 125 mg/m^2 administered in combination with gemcitabine 1000 mg/m^2 weekly for 3 weeks followed by one week of rest.

Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m^2 administered in combination with Gemcitabine 1000 mg/m^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest

Gemcitabine

Gemcitabine, 1000 mg/m^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).

Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

The Karnofsky Performance Status Scale (KPS) was designed to measure the level of participant activity and medical care requirements. A general measure of participant independence and has been widely used as a general assessment of participants with cancer. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. The primary purpose of its development was to allow physicians to evaluate a participant's ability to survive chemotherapy for cancer. Two participants from the Albumin bound paclitaxel arm and one from the Gemcitabine arm did not have KPS performed.

[2]

Main location or area of the pancreas where the disease is detected at diagnosis. Unknown location refers to disease area not being specified.

[3]

Target lesions are those measurable at baseline and are generally the largest lesions, most reliably measured and most representative of the participants sites of disease. Non target lesions are all of the sites of disease present at baseline not classified as target lesions. They include bone and cystic lesions and pleural/pericardial effusion/ascites. The Independent Radiology Reviewers (IRR) only evaluated scans for those with baseline and follow-up scans.

Progression-free Survival (PFS) by Independent Radiological Review (IRR) [ Time Frame: Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months. ]

The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.

Time Frame

Maximum time on treatment was 666 days

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Treated Population

Reporting Groups

Description

Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)

Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest

Gemcitabine (Gem)

Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)

Measured Values

Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)

Gemcitabine (Gem)

Number of Participants Analyzed
[units: participants]

421

402

Number of Participants With Dose Reductions
[units: participants]

At least 1 alumbin bound paclitaxel dose reduction

172

0

At least 1 Gemcitabine dose reduction

198

132

No statistical analysis provided for Number of Participants With Dose Reductions

6. Other Pre-specified:

Number of Participants With Dose Interruptions [ Time Frame: Maximum time on treatment was 666 days ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Authorship/contents of any publication is determined by site and provides sponsor a publication prior to submission. Sponsor has 60 days to review and avoid editorial changes but may request site delete confidential data. If publication contains patentable matter, site agrees to delay publication for 60 days. If study is part of multicenter protocol, site agrees not to independently publish. If multicenter publication is not forthcoming in 18 months after study end, site may proceed accordingly.